The Center’s delegation, headed by Director Mykhailo Babenko, is participating in the 113 meeting of the Heads of Medicines Agencies (HMA). The event takes place on 18-22 September 2023 in Santiago de Compostela (Spain).
The delegation included, in addition to the Director, Deputy Director for Registration and Pharmacovigilance Yevheniia Tkachenko and Head of the Quality Methodological Support Division Olha Sadovnycha.
Over the two days of the HMA Meeting – participation in session meetings and discussions on antimicrobial resistance (AMR), national action plans, implementation of AMR recommendations and other important issues.
At the beginning of the first day of work, the heads of the Agencies were addressed with welcoming remarks by José Manuel Miñones, Minister of Health (Spain), and María Lamas, executive director of the Spanish regulator AEMPS. Ms. María drew the guests' attention to the presence of the Ukrainian delegation in the hall and expressed words of support for Ukraine, confirmed her interest in deepening cooperation and her readiness to provide assistance in the further integration of our country into the European Union and in strengthening its regulatory system in the sphere of medicinal product circulation.
The first part of the plenary session was devoted to organizational issues, progress of activities, and ongoing projects. The following addressed the participants: Chair of the HMA Management Group Karl Broich presented the Report of the HMA Management Group; Lorraine Nolan, Health Products Regulatory Authority (HPRA) of Ireland – her presentation concerned discussion of the HMA concept. Also taking part in the meeting were Emer Cooke, Executive Director of the EMA, and Olga Solomon, Head of Unit for Medicinal Products (Policy, Authorization, Monitoring) at the Directorate-General for Health of the European Commission DG SANTE. They presented updated information from the institutions.
The second part of the plenary session was devoted to antimicrobial resistance.
Also, on the first day of the HMA Meeting, delegates considered the issue of vital medicinal products for Europe and updated data from the EMA Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh).
On the final day of the Meeting, our representatives took part in the Joint Meeting of the competent authorities for the regulation of medicinal products (HMA) and medical devices (CAMD).
The purpose of the session was to highlight issues related to the regulatory aspects of interaction between the two sectors and EU experience.
In particular, the implementation of the COMBINE project was discussed, which regulates the interaction between the In Vitro Diagnostic Medical Devices Regulation (IVD), the Medical Devices Regulation (MDR) and the Clinical Trials Regulation (CTR), as well as interaction on HTA issues.
During the final plenary session, the report of the Benchmarking of European Medicines Agencies Steering Group (BEMA SG) was heard. The results of the discussions on the prospects for the development of the NMA network and the role of external and internal communications as a strategic element of development were also heard.
Summing up the meeting, the heads of the HMA, EMA and the European Commission highly appreciated the work of all members and participants of the 113 Meeting on the path to protecting and strengthening healthcare systems in Europe and ensuring effective and efficient regulatory activities.
